Solifenacin Sandoz

Patient Information Leaflet

Solifenacin Sandoz 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Solifenacin Sandoz is and what it is used for
2. What you need to know before taking Solifenacin Sandoz
3. How to take Solifenacin Sandoz
4. Possible side effects
5. How to store Solifenacin Sandoz
6. Contents of the pack and other information

1. What Solifenacina Sandoz is and what it is used for

Solifenacin, the active substance in Solifenacina Sandoz, belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This helps delay the need to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacina Sandoz is used to treat the symptoms of a condition called overactive bladder. These symptoms include:

• a sudden, strong urge to urinate without prior warning
• the need to urinate frequently
• leakage because you cannot reach the toilet in time

2. What you should know before taking Solifenacin Sandoz

Do not take Solifenacin Sandoz
if:
you are allergic to solifenacin or to any of the other ingredients of this medicine (listed
in section 6)
you have difficulty passing urine or completely emptying your bladder (urinary retention)
you have a serious stomach or bowel problem (including toxic megacolon, a complication associated with ulcerative colitis)
you have a muscle disease called myasthenia gravis, which causes extreme weakness of certain muscles
you have increased pressure in the eye with gradual loss of vision (glaucoma)
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you are undergoing kidney dialysis
you have severe liver disease
you have severe kidney disease or moderate liver disease and are being treated at the same time with medicines that may reduce the elimination of Solifenacin Sandoz from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you about this, if applicable.
Inform your doctor if you have or have previously had any of the conditions listed above before starting treatment with Solifenacin Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Sandoz
if you have problems emptying your bladder (bladder obstruction) or have difficulty passing urine (e.g. reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
if you have gastrointestinal obstructions (constipation).
if your gastrointestinal motility (movements of the stomach and intestines) is at risk of slowing down. Your doctor will inform you about this possibility.
if you have severe kidney disease.
if you have moderate liver disease.
if you have a stomach condition (hiatal hernia) or heartburn.
if you have a nerve disorder (autonomic neuropathy).
Inform your doctor if you have or have previously had any of the conditions listed above before starting treatment with Solifenacin Sandoz.

Before starting treatment with Solifenacin Sandoz, your doctor must evaluate whether there are other causes for your frequent need to urinate (e.g. heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and adolescents
Solifenacin Sandoz must not be used in children or adolescents under 18 years of age.

Other medicines and Solifenacin Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:
other anticholinergic medicines, as they may increase the effectiveness and side effects of both medicines.
cholinergic agents, as they may reduce the effect of Solifenacin Sandoz.
medicines such as metoclopramide and cisapride, which speed up digestive system activity. Solifenacin Sandoz may reduce their effect.
medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of Solifenacin Sandoz from the body.
medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of Solifenacin Sandoz from the body.
medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).
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Solifenacin Sandoz with food and drink
Solifenacin Sandoz may be taken with or without food, as preferred.

Pregnancy and breastfeeding
Pregnancy
You must not use Solifenacin Sandoz during pregnancy unless strictly necessary.
Breastfeeding
Do not use Solifenacin Sandoz if you are breastfeeding, as solifenacin may pass into your breast milk.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Solifenacin Sandoz may cause blurred vision and sometimes drowsiness or fatigue. If you experience these side effects, do not drive or operate machinery.

Solifenacin Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Solifenacin Sandoz

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 5 mg once daily, unless your doctor has instructed you to take 10 mg daily.
Swallow the tablets whole with a glass of water, without chewing or crushing them.
Solifenacin Sandoz 10 mg film-coated tablets
The tablets may be divided into equal doses. Swallow the tablets or halves with a glass of water, without chewing or crushing them.
Take the tablets at the same time each day. The tablets may be taken regardless of meals.

If you take more Solifenacin Sandoz than you should
If you have taken too much Solifenacin Sandoz or if a child has accidentally ingested it, contact your doctor or pharmacist immediately.
Symptoms of overdose may include:
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headache
dry mouth
dizziness
drowsiness and blurred vision
perception of non-existent objects (hallucinations)
overexcitation
seizures (convulsions)
difficulty breathing
increased heart rate (tachycardia)
urine retention in the bladder (urinary retention)
dilated pupils (mydriasis).

If you forget to take Solifenacin Sandoz
If you forget to take a dose at your usual time, take it as soon as you remember, unless it is almost time for your next dose. Never take more than one dose per day. If you are unsure, always consult your doctor or pharmacist.

If you stop taking Solifenacin Sandoz
If you stop taking Solifenacin Sandoz, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following side effects, stop taking Solifenacina Sandoz and contact your doctor immediately:
Allergic reaction (signs may include swelling of the throat, face, lips and mouth, difficulty breathing or swallowing) or a severe skin reaction (e.g. blistering and peeling of the skin).
Angioedema (an allergic skin reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin.

Other side effects may occur with the following frequencies:
Very common – may affect more than 1 in 10 people
dry mouth

Common – may affect up to 1 in 10 people
blurred vision
constipation
nausea
indigestion with symptoms such as abdominal fullness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon – may affect up to 1 in 100 people
urinary tract infection, bladder infection
drowsiness, fatigue
taste disturbance (dysgeusia)
dry (irritated) eyes
nasal dryness
reflux disease (gastroesophageal reflux)
dry throat
dry skin
difficulty urinating
fluid accumulation in the lower legs (oedema)

Rare – may affect up to 1 in 1,000 people
accumulation of large amounts of hardened faeces in the colon (faecal impaction)
increased urine formation in the bladder due to inability to empty the bladder (urinary retention), dizziness, headache
vomiting
itching, rash

Very rare – may affect up to 1 in 10,000 people
hallucinations, confusion
allergic skin rash

Not known – frequency cannot be estimated from the available data
decreased appetite, high levels of potassium in the blood which may cause heart rhythm abnormalities
increased intraocular pressure
changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat
voice disorders
liver disease
muscle weakness
kidney disorders

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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The shelf life after first opening the polyethylene bottle is 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Solifenacina Sandoz contains
Solifenacina Sandoz 5 mg film-coated tablets
The active substance is solifenacin succinate. Each film-coated tablet contains 5 mg of
solifenacin succinate, equivalent to 3.8 mg of solifenacin.
The other ingredients are monohydrate lactose, hypromellose, pregelatinized starch, magnesium
stearate, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
Solifenacina Sandoz 10 mg film-coated tablets
The active substance is solifenacin succinate. Each film-coated tablet contains 10 mg of
solifenacin succinate, equivalent to 7.5 mg of solifenacin.
The other ingredients are monohydrate lactose, hypromellose, pregelatinized starch, magnesium
stearate, macrogol 6000, talc, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of Solifenacina Sandoz and package contents
Solifenacina Sandoz 5 mg film-coated tablets are light yellow, round, film-coated tablets, 6 mm in diameter, with the number "05" printed on one side.
Solifenacina Sandoz 10 mg film-coated tablets are light pink, round, film-coated tablets, 8 mm in diameter, with the number "10" printed on one side and a breakline on the other side.
The tablet can be divided into equal doses.
The tablets in PVC/Al blisters contain 10, 20, 30, 50, 90 or 100 film-coated tablets packed in a box.
Polyethylene bottles (with a polypropylene screw cap/desiccant) contain 30, 56, 60, 84, 90, 100, 105 or 250 film-coated tablets packed in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
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Lek Pharmaceuticals d. d.
Verovškova ulica 57,
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d. d.
Trimlini 2D
9220 Lendava
Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Solifenacin Sandoz 5 mg film-coated tablets
Solifenacin Sandoz 10 mg film-coated tablets
France SOLIFENACINE SANDOZ 5 mg, comprimé pelliculé
SOLIFENACINE SANDOZ 10 mg, comprimé pelliculé
Ireland Solifenacin succinate Rowex 5 mg Film-coated tablets
Solifenacin succinate Rowex 10 mg Film-coated tablets
Italy Solifenacina Sandoz
Germany Solifenacin HEXAL 5 mg Filmtabletten
Solifenacin HEXAL 10 mg Filmtabletten
Netherlands Solifenacinesuccinaat Sandoz 5 mg, filmomhulde tabletten
Solifenacinesuccinaat Sandoz 10 mg, filmomhulde tabletten
United Kingdom Solifenacin succinate 5 mg Film-coated Tablets
Solifenacin succinate 10 mg Film-coated Tablets
Romania Solifenacin Sandoz 5 mg comprimate filmate
Solifenacin Sandoz 10 mg comprimate filmate
Slovenia Solifenacin Sandoz 5 mg filmsko obložene tablete
Solifenacin Sandoz 10 mg filmsko obložene tablete
Sweden Solifenacin Sandoz 5 mg filmdragerad tablett
Solifenacin Sandoz 10 mg filmdragerad tablett
Hungary Solifenacin Sandoz 5 mg filmtabletta
Solifenacin Sandoz 10 mg filmtabletta
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